Lesotho, a small, landlocked country completely surrounded by South Africa, is among the world's poorest nations with one of the world's most severe epidemics of HIV and tuberculosis (TB). There is strong evidence that TB patients who are also infected with HIV have better survival rates if they begin antiretroviral therapy (ART) soon after starting TB treatment; however, there are many patients who do not initiate ART within the recommended timeframe, and who do not remain in care.

The purpose of the START Study is to identify an effective, cost-effective, acceptable intervention that addresses programmatic, structural and psychosocial barriers to ART initiation and retention during TB treatment, with the ultimate goal of improving health outcomes among HIV-infected TB patients in Lesotho. The study is a two-arm cluster randomized trial, randomized at the TB/HIV clinic level, which includes twelve TB/HIV clinics in Berea district. Clinics are randomized to deliver the combination intervention package (CIP) or standard of care (SOC), with stratification by facility type. The experimental intervention will be delivered to all HIV-infected TB patients in TB/HIV clinics randomly assigned to CIP. In TB/HIV clinics assigned to SOC, usual care procedures for ART initiation and retention will be delivered.

Study hypotheses focus on the effectiveness of the CIP on HIV- and TB-related outcomes.

nurse training and mentorship in TB/HIV cotreatment using clinical algorithm

reimbursement of transportation costs to monthly clinic visits for patients and treatment supporters

health education using a TB/HIV treatment literacy curriculum for patients and treatment supporters

real-time adherence support using short message service (SMS) text messaging and trained village health workers.

Other: Combination Intervention Package

Standard of Care

At SOC clinics, usual procedures for management of HIV-infected TB patients will be followed. At health centers, TB and HIV services are fully integrated in a one-stop model, while at hospitals, ART is provided in the TB clinic for TB/HIV coinfected patients. Nurses, lay counselors, and VHW provide TB/HIV services. Lay counselors offer HIV counseling and testing to all TB patients. As per national guidelines, HIV-infected TB patients are to be started on ART two to four weeks after initiating TB treatment, regardless of CD4+ count. Directly observed therapy is usually provided in the community by a treatment supporter, who is usually a family member. TB/HIV patients return to the health facility monthly for a 30-day supply of medications and monitoring of side effects and adherence.

nurse or VHW working in a CIP clinic or VHW working in the community and affiliated with CIP clinic;

aged 18 or older;

English or Sesotho‐speaking;

capable of and willing to provide informed consent.

Key Informants Healthcare Workers Exclusion Criteria

Children under age 18

Nurse or VHW working in or affiliated with a SOC clinic

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872390